This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We’ll also cover the essentials of doing a failure investigation.
CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years’ experience. You will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems.
CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years’ experience. You will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems.
Susanne Manz
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a …
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Introduction to Generative AI for Accountants
Dealing With Difficult People In Life & Work
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
How to Write Effective Audit Observations: The Principles f…
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
FDA Regulation of Artificial Intelligence/ Machine Learning
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
Marketing to Medicare or Medicaid Beneficiaries - What You …
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Tattoos, hijabs, piercings, and pink hair: The challenges …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Humane Layoffs: How to Let People Go with Compassion and De…
Onboarding is NOT Orientation - How to Improve the New Empl…
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …